1. Field of the Invention
This invention relates to the closed compression technique for rupturing a contracted fibrous capsule after augmentation mammaplasty and more particularly is directed to an instrument in the form of a manually operated compressor capable of achieving the initial "pop" in performing said technique.
2. Description of the Prior Art
A common complication after augmentation mammaplasty, whereby a coated silicone gel prosthesis is implanted through a submammary incision, is the development of excessive firmness, usually due to contraction of the fibrous capsule surrounding the prosthesis and producing a more spherical configuration. This condition becomes uncomfortable for the patient to lie on and is a possible source of embarrassment when touched. The cause of the condition is believed to be a problem of scar contraction, in these cases being a 3-dimensional spheroidal scar. This complication may be corrected by a surgical procedure, namely, a capsule release, which divides the capsule circumferentially near its base, involving the risks and disadvantages of surgery coupled with the possibility of the formation and contraction of a second capsule at a later date, again requiring surgical intervention.
As reported in an article by Baker, J. L. Jr., Bartels, R. J. and Douglas, W. M. in Plastic & Reconstructive Surgery, 1976, Vol. 58, Pages 137-141, by an odd coincidence, a patient having had augmentation mammaplasty and presenting this excessive firmness of the breast unilaterally was scheduled for an operative capsule release. Subsequently, the patient reported having been hugged by a large professional football player and squeezed very tightly, whereupon a loud popping sound was heard. Upon later examination, the patient found the excessively firm breast had become soft, which condition was confirmed by the surgeon in finding the breast soft and non-tender and showing no evidence of ecchymosis, hematoma, or other complication and, therefore, not requiring the scheduled surgery. Based on this report and findings, subsequent trials duplicating this squeeze technique were performed by the surgeon on other patients and proved successful. The technique developed for this purpose involves grasping the breast circumferentially in both hands in strangle-hold fashion and applying a circumferential compressive force by squeezing with the fingers until an initial "pop" is heard indicating the rupture of the capsule and thereafter a follow-through twist is applied to effect complete release of the implant circumferentially rather than a localized tear through which the implant may extrude into one of the quadrants of the breast to produce a dumbbell-shaped distortion.
A difficulty arises in supplying the force required to achieve this initial "pop", relative little force being required for the follow-through. Not only is sufficient strength in the fingers and hands of the operator often lacking to perform the strangle-hold technique, but the force exerted may result in damage to the operator's thumbs or fingers which is highly undesirable to any surgeon performing the technique. Other hand techniques have been utilized, for example, the palm compression or nut-cracker method, wherein the fingers are interlocked and pressure applied on opposite sides of the breast by the heels of the palms, and the closed fist crush, wherein the breast is positioned between clenched fists held either knuckles up or down and a squeezing force applied parallel to the chest wall utilizing the greater power of the pectoral and upper arm muscles of the operator as compared to the muscles of the forearm used in performing the strangle-hold method. Both these other techniques have been found to be awkward and unreliable by failing to ensure the proper grasping and surrounding of the base of the implant, as is accomplished in the strangle-hold technique, to produce the intracapsular force needed to rupture the capsule. For example, in the palm compression method, the hands may be too small to encompass the base of the implant, while in the closed fist crush it is difficult to maintain the fists in position in close proximity to the chest wall while applying the necessary force parallel to the chest wall. Thus, both these techniques, where greater force is available, experience difficulty in preventing the undesirable shifting of the implant in a direction at right angles to the application of the force.
Since the ability to stop short, that is, to exercise control of movement, appears to decrease to perhaps a vanishing point as the exerted force approaches a maximum capability of the muscles, there is also a significant danger, particularly in the nut-cracker and closed fist crush, of the operator applying excessive force and thereafter not being able to stop in time, whereby the coating or skin of the silicone gel may also rupture and require prompt remedial surgery.
There is, therefore, a current need for a reliable means for performing the closed compression method which will provide the advantages of the circumferential application of compressive force of the strangle-hold technique and will develop superior force exceeding that of the other techniques while eliminating the drawbacks and problems hereinbefore mentioned.